Prevention of Delirium After Bone Marrow Transplantation

Massachusetts General Hospital40 enrolled

Overview

The purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium.

This is a pilot, double blind randomized study conducted in patients scheduled to undergo bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to look at the usefulness of bright light therapy in the prevention of delirium in a population at high risk for developing this condition. Delirium can develop in up to half of the people that undergo bone marrow transplant. Symptoms include changes in level of alertness, confusion, and temporary problems with memory and attention. In severe cases, it can be accompanied by agitation, paranoia(overly suspicious), and hallucinations(seeing or hearing things that are not really there). Bright light uses no medication and is often used to treat seasonal affective depression and multiple sleep disorders. The light boxes are portable and are placed in front of individuals for about 30 minutes every day.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Delirium

Interventions

Bright light therapyDEVICE

The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Sham lightDEVICE

The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 or older * Male or female * Patients scheduled to undergo HSCT * English speaking Exclusion Criteria: * Previous history of bipolar affective disorder * On-going delirium * History of substance abuse/dependence within 6 months prior to HSCT * History of invasive melanoma. Patients with a history of basal cell carcinoma, melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s) have been excised with negative margins * History of medical/dermatological conditions that make skin especially sensitive to light,such as systemic lupus erythematosus (SLE) and/or porphyria * Eye condition that makes eyes vulnerable to light damage * Concomitant use of medications that increase sensitivity to sunlight, such as the herbal supplement St. John's Wort * Established primary insomnia

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale

Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)

Time frame: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant

Secondary Outcomes

Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)

Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first. 10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30. A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium

Time frame: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant

Average Dose of Antipsychotic Medications Required to Manage Delirium

Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant

Hospital Length of Stay

Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant

Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)

Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).

Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant

Data from ClinicalTrials.gov

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